ElevateBio Receives ICMC Certification for CGT Manufacturing Capabilities

ElevateBio, a technology-driven company focused on powering the creation of genetic medicines, has received comprehensive certification from the Initiative for Certification of Manufacturing Capabilities (ICMC) program for its viral gene delivery, non-viral gene delivery, and cell therapy manufacturing capabilities at its flagship ElevateBio BaseCamp facility in Waltham, Massachusetts.

The ICMC certification, administered by Dark Horse Consulting (DHC), is designed to address the industry’s most critical manufacturing challenges through assessment of capabilities to help reduce regulatory risk, accelerate development timelines, and increase probability of technical success. Through the certification process, DHC evaluates nine comprehensive systems, expanding upon the seven systems outlined in FDA’s CBER Compliance Program Guidance Manual Chapter 45 for Biological Drug Products and incorporating EU Directive 2003/94/EC standards.

“This comprehensive ICMC certification represents the most rigorous third-party manufacturing evaluation available in our industry today,” said Michael Paglia, Chief Technology Officer at ElevateBio BaseCamp. “This certification across cell therapy, viral vector, and mRNA modalities underscores our unique capability to support a diverse range of advanced genetic medicine technologies and demonstrates our readiness to seamlessly scale manufacturing from clinical through commercial stages, enabling our partners to accelerate their path to market without manufacturing disruptions.”